TCORS Grant Brings Behavior and Health Research Funding Total to $34.7 Million

In a single week, the efforts and expertise of University of Vermont (UVM) Professor of Psychiatry Stephen T. Higgins, Ph.D., and colleagues at the College of Medicine have attracted an unprecedented $34.7 million in federal funding to support behavior and health research at the University. The latest boost to UVM’s new Vermont Center on Behavior and Health – supported by an $11.5 million National Institutes of Health Institutional Development Award Center of Biomedical Research Excellence grant announced September 16 – is a prestigious five-year, $19.5 million Tobacco Centers of Regulatory Science (TCORS) award from the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Higgins has also received notification of a five-year, $3.7 million NIH grant for another smoking-related study, titled “Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women.”

The FDA and NIH formed an interagency partnership to fund TCORS – a new, first-of-its-kind regulatory science tobacco program, which is designed to generate research to inform the regulation of tobacco products to protect public health. Despite decades of work to reduce tobacco use, it continues to be the leading cause of preventable death and disease, with cigarette smoking alone responsible for more than 440,000 premature deaths in the U.S. annually. UVM is one of 14 institutions nationwide to obtain this prestigious award.

Using designated funds from FDA, TCORS will be coordinated by NIH’s Office of Disease Prevention, directed by David M. Murray, Ph.D., and administered by three NIH institutes – the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung and Blood Institute.

The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identified a targeted research goal. Taken together, the TCORS sites will increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.

The TCORS will reside within UVM’s new Vermont Center on Behavior and Health, which serves as a foundation for the UVM Neuroscience, Behavior and Health Initiative. Higgins, who serves as director of the recently-announced Vermont Center on Behavior and Health, and is a nationally recognized expert in addiction, contingency management and behavioral economics, will direct the UVM TCORS. John Hughes, M.D., UVM professor of psychiatry and an international expert in smoking cessation research, will serve as the TCORS associate director. In addition, internationally recognized collaborators and consultants from Brown University (Jennifer Tidey, Ph.D.), Johns Hopkins University (Maxine L. Stitzer, Ph.D.), University of Minnesota (Dorothy Hatsukami, Ph.D.), and University of Pittsburgh (Eric Donny, Ph.D.), will support the UVM Center’s research. The TCORS will reside within the Vermont Center of Behavior and Health at UVM, which serves as a foundation for the University’s Neuroscience, Behavior and Health Initiative.

The TCORS grant marks the first P50 award to be received at the University of Vermont. According to the NIH, P50 grants – which are categorized as “specialized center” grants – are usually developed in response to an announcement of the programmatic needs of an Institute or Division and centers receiving this funding may serve as regional or national resources for special research purposes. “The University of Vermont has a long history and extensive expertise in the field of changing unhealthy behaviors like smoking and drug addiction in vulnerable populations,” says Higgins. “We are honored to be a recipient of this prestigious TCORS award and look forward to exploring the impact of tobacco addiction from multiple perspectives, including behavioral, cardiovascular, pulmonary, women’s reproductive health.”

Comprising scientists with expertise in fields including epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications, and marketing, the TCORS program is the centerpiece of the FDA/NIH collaboration to foster research relevant to tobacco regulatory science. New research from TCORS will help inform and assess the impact of FDA’s prior, ongoing and potential future tobacco regulatory activities implemented by CTP under the direction of Mitch Zeller, J.D. In addition, the TCORS investigators will have the flexibility and capacity to begin new research to address issues raised in today’s rapidly evolving tobacco marketplace.

The TCORS awards represent a significant investment in federal tobacco regulatory science, including $53 million in the first year and a potential total of more than $273 million over the next five years. TCORS funding may not exceed $4 million in total costs per year per center, and an investigator could request a project period of up to five years.

Designed to generate vital research in seven core areas, as well as ensure innovation in the field, the research supported by this initiative will provide scientific evidence within the following seven FDA tobacco-related research interest areas: diversity of tobacco products; reducing addiction; reducing toxicity and carcinogenicity; adverse health consequences; communications; marketing of tobacco products; and economics and policies.

In addition, TCORS sites are required to train the next generation of tobacco regulatory scientists, a charge that Higgins and colleagues say will be central to the Vermont TCORS mission. For nearly a quarter-century, UVM has maintained a well-regarded NIH-supported predoctoral and postdoctoral training program in addictions research under the direction of Higgins, with assistance from Hughes, and Associate Professors of Psychiatry Sarah Heil, Ph.D., and Stacey Sigmon, Ph.D. In collaboration with Tidey and Stitzer at Brown and Johns Hopkins University, the TCORS investigators will be able to double the size of this training program, dedicating half of the new positions to tobacco research.

Heil, Sigmon, and Diann Gaalema, Ph.D., assistant professor of psychiatry, will lead the multi-site clinical trials at the core of the UVM TCORS.

According to Sigmon, “The multidisciplinary Vermont TCORS will provide the FDA with critically important scientific support essential to its regulatory responsibilities, new knowledge on reducing the addictiveness of tobacco products and associated adverse health consequences in vulnerable populations, and the next generation of well-prepared scientists to carry on this important public health mission.”

The other 13 TCORS have been awarded to investigators at: American Heart Association, Dallas, Tx.; University of Maryland, College Park, Md.; Virginia Commonwealth University, Richmond, Va.; Georgia State University, Atlanta, Ga.; University of California-San Francisco; University of Pennsylvania, Philadelphia, Pa.; Yale University, New Haven, Conn.; Penn State University Hershey Medical Center, Hershey, Pa.; University of Southern California, Los Angeles, Calif.; University of Texas Health Sciences Center, Houston, Tx.; University of North Carolina at Chapel Hill; The Ohio State University, Columbus, Ohio.